CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 70 enrolled
Drug / intervention
RO7020531 +1 moredrug
Likely dose
RO7020531 170 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03530917
NCT03530917Phase 1Completed

A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020531 and Metabolites Following Oral Administration to Chinese Healthy Volunteers.

Hoffmann-La Roche·interventional·Posted May 21, 2018·Updated Jul 13, 2020

In Brief

A Phase 1 clinical trial evaluating RO7020531 and Placebo for Healthy Participants. Completed, enrolled 70 participants across 1 site.

Detailed Summary

To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 21, 2018
Enrollment StartMay 15, 2018
Primary CompletionMay 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 8.1 years ago

Interventions

RO7020531drug

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

Placebodrug

Placebo hard capsules will be administered orally as per the dosing schedules described above.